Trial Outcomes & Findings for Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis (NCT NCT05882812)
NCT ID: NCT05882812
Last Updated: 2025-05-15
Results Overview
Change in the self described pain units on a scale by patient at baseline and post-treatment. Higher scores mean a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
End of 8 weeks
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
SAM Ultrasound Device and Diclofenac Patch
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3 megahertz(MHz) frequency and 0.132 watts/cm\^2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm\^2 with 2.5% Diclofenac patches.
|
SAM Ultrasound Device and SAM Patch
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with SAM patch(0% diclofenac).
Sustained Acoustic Device with 0% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
|
Diclofenac Patch
Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 8 weeks combined.
2.5% Diclofenac Patches: Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
67
|
67
|
|
Overall Study
COMPLETED
|
64
|
64
|
64
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SAM Ultrasound Device and Diclofenac Patch
n=66 Participants
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3 megahertz(MHz) frequency and 0.132 watts/cm\^2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm\^2 with 2.5% Diclofenac patches.
|
SAM Ultrasound Device and SAM Patch
n=67 Participants
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with SAM patch(0% diclofenac).
Sustained Acoustic Device with 0% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
|
Diclofenac Patch
n=67 Participants
Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 8 weeks combined.
2.5% Diclofenac Patches: Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=66 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=200 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=66 Participants
|
52 Participants
n=67 Participants
|
51 Participants
n=67 Participants
|
155 Participants
n=200 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=66 Participants
|
15 Participants
n=67 Participants
|
16 Participants
n=67 Participants
|
45 Participants
n=200 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=66 Participants
|
41 Participants
n=67 Participants
|
34 Participants
n=67 Participants
|
110 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=66 Participants
|
26 Participants
n=67 Participants
|
33 Participants
n=67 Participants
|
90 Participants
n=200 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: End of 8 weeksChange in the self described pain units on a scale by patient at baseline and post-treatment. Higher scores mean a worse outcome.
Outcome measures
| Measure |
SAM Ultrasound Device and Diclofenac Patch
n=64 Participants
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3 megahertz(MHz) frequency and 0.132 watts/cm\^2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm\^2 with 2.5% Diclofenac patches.
|
SAM Ultrasound Device and SAM Patch
n=64 Participants
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with SAM patch(0% diclofenac).
Sustained Acoustic Device with 0% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
|
Diclofenac Patch
n=64 Participants
Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 8 weeks combined.
2.5% Diclofenac Patches: Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
|
|---|---|---|---|
|
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain (Value at 8 Weeks Minus Value at Baseline).
|
-3.7 units on a scale
Standard Error 0.25
|
-3.02 units on a scale
Standard Error 0.21
|
-1.61 units on a scale
Standard Error 0.22
|
PRIMARY outcome
Timeframe: End of 8 weeksWOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). Higher values represent a worse outcome, and lower values represent a better outcome.
Outcome measures
| Measure |
SAM Ultrasound Device and Diclofenac Patch
n=64 Participants
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3 megahertz(MHz) frequency and 0.132 watts/cm\^2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm\^2 with 2.5% Diclofenac patches.
|
SAM Ultrasound Device and SAM Patch
n=64 Participants
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with SAM patch(0% diclofenac).
Sustained Acoustic Device with 0% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
|
Diclofenac Patch
n=64 Participants
Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 8 weeks combined.
2.5% Diclofenac Patches: Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
|
|---|---|---|---|
|
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Value at 8 Weeks Minus Value at Baseline)
|
-23.42 units on a scale
Standard Error 2.10
|
-23.02 units on a scale
Standard Error 2.12
|
-14.55 units on a scale
Standard Error 2.04
|
Adverse Events
SAM Ultrasound Device and Diclofenac Patch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAM Ultrasound Device and SAM Patch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diclofenac Patch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place